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IQVIA
IQVIA
Sponsor pentru viza H1BConsultanțăIndustria prelucrătoareMarketing
IQVIA combină analiza datelor din domeniul sănătății, tehnologia avansată și serviciile de consultanță pentru a ajuta organizațiile să abordeze provocări complexe din sectoarele științelor vieții și al asistenței medicale. Platforma sa Connected Intelligence reunește date și inteligență artificială pentru a sprijini cercetarea clinică, dezvoltarea tehnologică și progresul unor terapii noi. Echipele companiei lucrează în domeniile analizei datelor, consultanței și tehnologiei medicale, oferind oportunități legate de cercetare, inovare digitală și eforturi de îmbunătățire a rezultatelor pentru pacienți.
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Clinical Data Specialist – IQVIA, Bloemfontein Onsite

IQVIA is seeking a Clinical Data Specialist in Bloemfontein to validate clinical trial databases and oversee testing, audits, documentation, and quality activities. The role supports database delivery across clinical studies, including Edit Check reconciliation, risk management, stakeholder coordination, and continuous process improvement.

ZAAfrica de SudLa sediuNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăGeneralSpecialist clinic

Descriere

  • Perform database validation activities and provide expertise to support the delivery of high-quality clinical databases
  • Lead database audits and oversee validation work across assigned studies
  • Own the quality, accuracy, and timely completion of database validation activities
  • Test clinical trial databases and review or update database specifications as needed
  • Create, document, and maintain test cases in the Data Management Plan (DMP)
  • Reconcile Edit Check status prefixes using DMP reconciliation reports
  • Update Edit Check statuses in the DMP and Clinical Trial Database (CTDB) where applicable
  • Identify erroneous Edit Checks and communicate them to database programmers for correction
  • Escalate document updates, discrepancies, and uncertainties to the Lead Data Manager
  • Follow core operating procedures, quality standards, and work instructions
  • Build and maintain relationships with Clinical Data Management teams and cross-functional stakeholders
  • Lead continuous process improvement initiatives and support organizational change
  • Apply advanced knowledge of database structures, validation methods, and testing processes
  • Support the Testing Lead with project documentation and stakeholder communications
  • Provide deputy or backup coverage for the Testing Lead when required
  • Act as a subject matter expert for database validation and testing activities
  • Mentor, train, and support the onboarding of new team members
  • Participate in project and study team meetings
  • Review project plans and identify, escalate, and mitigate risks and issues
  • Manage testing activities end to end, including resource planning, workload management, and delivery oversight
  • Track project timelines and ensure testing deliverables meet agreed deadlines
  • Perform quality reviews and audits for compliance with study requirements and regulatory standards
  • Maintain relationships with internal customers and key stakeholders
  • Support risk management by identifying potential challenges and escalating concerns to management
  • Contribute to process optimization and best-practice implementation across testing and validation
  • Maintain accurate documentation, tracking, and reporting of testing outcomes and validation findings
  • Support database build, testing, deployment, and maintenance throughout the clinical trial lifecycle

Cerințe

  • Bachelor’s degree in clinical, biological, mathematical sciences, or a related field
  • Equivalent education, training, and experience may substitute for the degree
  • Exposure to medical terminology
  • Strong organizational, communication, leadership, and computer skills
  • Exceptional attention to detail
  • Ability to work independently and take initiative to resolve problems
  • Ability to build and maintain effective working relationships with coworkers, managers, and clients

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